A Prospective Single-center Cohort Study of Surgical Treatment of Chronic Rhinosinusitis

NCT06010316 | Unknown

• 1 other identifier: TR-surgical treatment of CRS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Rhinosinusitis (CRS) is a common and frequent disease in otorhinolaryngology. The main symptoms of patients include nasal congestion, runny nose, swelling pain of the frontal area and decreased sense of smell. Chronic rhinosinusitis refers to chronic rhinosinusitis with symptoms lasting ≥12 weeks and can be divided into two subgroups: chronic rhinosinusitis with and without nasal polyps. Chronic rhinosinusitis has a complex pathogenesis, there are three main pathogenic factors: infection, allergy and nasal and sinus anatomic abnormalities, these factors are often not a single existence, but often intertwined. In addition, environmental factors, genetic factors, osteitis, gastroesophageal reflux disease, respiratory ciliary system defects, systemic immune dysfunction and other secondary risk factors. For patients with chronic sinusitis, these symptoms, such as nasal congestion, runny nose, swelling pain and decreased sense of smell, often seriously affect their quality of life, and even evolve into more serious complications as the disease progresses. At present, the conventional treatment methods mainly include drug conservative treatment and nasal endoscopic surgery. Functional nasal endoscopic sinus surgery (FESS) is the main method of further surgical treatment for patients with no obvious effect of drug treatment. In FESS, the current emphasis is on removing diseased tissue and restoring sinus drainage on the premise of preserving the normal mucosa and physiological structure of the nasal and nasal sinuses as much as possible. Up to now, there have been many studies on surgical treatment of CRS, and the quality of the studies varies. However, in view of the postoperative efficacy and long-term prognosis of different subtypes of CRS, different treatment methods during surgery and different drug therapy regimens, our research group believes that it is necessary to accumulate a large amount of clinical data support through in-depth research and comprehensive analysis. Thus more reliable conclusions can be drawn. In this study, patients undergoing CRS surgery in the research ward of the Department of rhinosinusitis will be actively included through a prospective single-center cohort study to provide evidence for evidence-based medicine and better guide clinical rhinologists to make surgical treatment decisions for patients with chronic rhinosinusitis.

Conditions

Chronic Rhinosinusitis (Diagnosis); Cohort Study; Evidence-based Medicine

Outcome Measures

Primary Outcomes (1)

• The change in Total Nasal Symptom Score (TNSS).

  TNSS is used to assess the severity of nasal symptoms (runny nose, nasal congestion, hyposmia, sneezing): 0 = asymptomatic; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms. The sum of the scores of each symptom is used as the TNSS.

  Pre-operation, 1 year after surgery

Secondary Outcomes (9)

• The changes in VAS score.

  Pre-operation, 1 year after surgery

• The changes in SNOT-22 score.

  Pre-operation, 1 year after surgery

• The changes in asthma ACQ score.

  Pre-operation, 1 year after surgery

• The changes in Nasal Polyp Score (NPS) score.

  Pre-operation, 1 year after surgery

• The changes in sinus CT score.

  Pre-operation, 1 year after surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic sinusitis in the research ward of the Department of Rhinology, Beijing Tongren Hospital, Capital Medical University.

You may qualify if:

• (1) Meeting the CRS diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2018); (2) The effect of conservative drug treatment is not good or there are indications of surgery; (3) Good compliance, able to complete clinical observation. Compliance with guidelines

You may not qualify if:

• (1) The patient has conditions or co-existing diseases that may preclude the primary efficacy endpoint evaluation, such as benign or malignant tumors of the nasal cavity; (2) Clinically significant co-existing diseases that may interfere with clinical efficacy results, including but not limited to: Cystic fibrosis, eosinophilic granuloma with polyvasculitis (Churg-Strauss syndrome), granuloma with polyvasculitis (Wegener's granuloma), Young's synthesis, tuberculosis or other pathogen infection, malignancy, etc. (3) The patient had other medical or non-medical conditions that the investigator considered unsuitable for participation in the study.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 24, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)